Outpatient Versus Inpatient Balloon Catheter Induction of Labor

Turku University Hospital (TYKS)

Status: Completed

Conditions: Prolonged Pregnancy

Treatments: Other: Intervention is to let patient to go home.; Other: Intervention is to observe women in the ward.

Study type: Interventional

Funder types: Other

Identifiers

NCT02793609

T169/2016

Details and patient eligibility

About

Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.

Full description

The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.

The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.

Enrollment: 117 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• uncomplicated pregnancy
• singleton pregnancy
• pregnancy weeks between >37 and <41+5
• the patient is living in 1/2 hour away from hospital

Exclusion criteria

• patient has any disease or medication
• multiple pregnancy
• pregnancy week > 41+5
• preterm rupture of membranes
• patient living more than 1/2 hour away from hospital

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Outpatient group

Other group

Description:

After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.

Treatment:

Other: Intervention is to let patient to go home.

Inpatient group

Other group

Description:

After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.

Treatment:

Other: Intervention is to observe women in the ward.